FDAnews Device Daily Bulletin

Devicemakers seeking ISO 13485 certification can expect longer initial audits of their quality management systems (QMS), thanks to a new mandatory document by the International Accreditation Forum.

Medical devicemakers in Canada will now have to pay a fee to renew their establishment licenses annually by April 1, or face cancellation and enforcement actions, according to an updated Health Canada guidance.

People in developing countries with heart problems may not be able to afford new pacemakers, but a new study suggests devices removed during autopsies may have enough remaining battery life to be donated and used again.

Engineers in Britain have developed an ultrasound scanner that costs less than $65 to make and could improve prenatal care in parts of the developing world where this technology is out of reach.

Cook Medical has announced the launch of a new otolaryngology/head and neck surgery clinical division, according to a news release.

An analysis of data from Medtronic’s Symplicity HTN 2 renal denervation trial showed that the procedure is a cost-effective way to treat resistant hypertension, or high blood pressure.

In the wake of thousands of permanent injuries and lawsuits over defective medical devices, the FDA has proposed a new plan for postmarket medical device surveillance.

This new medical device doesn't require batteries because it's not powered by electricity.